Zentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. In the six years since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.
SUMMARY
Responsible for the day-to-day management of a diverse program of clinical trials, including management of contract CROs conducting company sponsored clinical trials.
RESPONSIBILITIES
- Work with CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed
- Work with CRO to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
- Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs; attend co-monitoring visits as required
- Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable
- Review and contribute to study Protocols, eCRF design and completion guidelines, pharmacy manuals, Informed Consent Forms, and other study-related documents
- Coordinate/plan investigator meetings and/or site and CRA training
- Perform financial management, including review and approval of site and vendor invoices
- Track and coordinate trial related materials, including clinical trial supplies and laboratory samples
- Perform review and QC central clinical files and trial master file
- Identify potential study issues and recommend and implement solutions or corrective actions as needed
- Serve as a liaison and resource for investigational sites, review investigator contracts and site payments
- Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs
- Organize and manage internal team meetings and other trial-specific meetings
- Participating in the development, review and implementation of departmental SOPs and processes
- Other projects as deemed appropriate
QUALIFICATIONS
- Bachelor’s degree or equivalent in a scientific or health care field is required with 6 years of clinical trial management experience
- Experience in CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance
- Clinical operations experience at a small or mid-size company
- Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out
- Experience working independently and in a team environment, being flexible and adapting in a changing environment
- Ability to travel up to 25%
- Ability to multi-task/ prioritize and time management of daily activities
- Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint)
- High attention to detail
- Demonstrates high level of accuracy and effective oral and written communication skills
- Flexibility within a rapidly changing environment
- Excellent ability to work in a goal and team-oriented setting
- Well-developed organizational skills
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